It is thought that reducing variability in the way healthcare is delivered can help control healthcare costs. Well-defined guidelines can improve reproducibility of care, and can contribute to a standard by which to measure and enhance quality. Increased consistency may also allow healthcare practitioners to be more efficient with their time, space, and personnel. Of course, a degree of variation is unavoidable, since healthcare practitioners must make treatment decisions based on their own knowledge and experience, an ever expanding constellation of complex details, and each individual patient's situation.
Biological products such as proteins and cells can be useful for the prevention, treatment, and/or cure of a disease or condition. These materials are very different from chemically synthesized drugs in that they are derived from living sources, are complex mixtures that may be difficult to fully characterize, and may have increased susceptibility to microbial contamination. Furthermore, while cells and tissues are useful for the repair, reconstruction, replacement or supplementation of a recipient's cells and/or tissues (as the case may be), utilization of such may sometimes be limited by a lack of availability and/or complications such as donor site morbidity, viability and/or compatibility, and/or due to immune system rejection.
Adipose tissue is loose connective tissue composed mostly of adipocytes and the stromal vascular fraction which includes preadipocytes, fibroblasts, vascular endothelial cells and a variety of immune cells. Adipose tissue is derived from preadipocytes and, in the case of white adipose tissue, its main role is to store energy in the form of lipids, although it also cushions and insulates the body. Brown adipose tissue also cushions and insulates the body but has the primary function of generating body heat. Adipose tissue is found in specific locations which are referred to as adipose deposits. Adipose deposits located in different parts of the body have different biochemical profiles. Many small blood vessels run through adipose tissue to provide support needed for its survival. Adipose tissue can be found in the integumentary system which includes the epidermis, dermis and hypodermis. The adipose tissue located just beneath the epidermis and dermis in the hypodermis is commonly referred to as subcutaneous tissue. Adipose tissue found around internal organs is commonly referred to as visceral fat. Visceral fat (also known as abdominal fat or organ fat) is located inside the abdominal cavity and packed in between organs such as the stomach, liver, intestines and kidneys. Intramuscular fat is interspersed in skeletal muscles.
Recently, there has been an increased focus on using adipose tissue as a source for so-called adipose stromal cells (“ASCs”) which are progenitor cells that can be used for cell therapy and other therapeutic purposes. There are individuals and entities that have made observations and assertions regarding the therapeutic benefits of ASCs (or any synonyms for such progenitor cells) and the means to achieve such benefits. However, attempts to commercialize the preparation of adipose tissue to access ASCs have been primarily directed at large-scale automated processes or smaller inefficient systems with limited effectiveness. An example of a system that embodies such a large-scale automated processes is that which is disclosed in U.S. Pat. Nos. 7,901,672, 8,105,580, and 8,119,121, the entire contents of each of which are hereby incorporated by reference for all they teach regarding ASCs (and synonyms for such progenitor cells), stem cell therapies, and tissue engineering.
Preparation of adipose tissue occurs after it has been harvested (removed) from a patient by a physician. The harvesting procedure typically involves infiltration of a patient's adipose tissue with a solution (often referred to as tumescent solution) that is typically a mixture of, but not limited to, saline, anesthetic, and epinephrine. A suction-based cannula technique is typically used to harvest adipose tissue and, along with it, much of the tumescent solution. Because this technique produces a mixture of adipose tissue and tumescent solution (which is typically referred to as lipoaspirate), it is necessary for a healthcare practitioner to separate the adipose tissue desired for therapeutic purposes from the lipoaspirate.
Use of adipose tissue for therapeutic purposes is routinely performed by physicians in surgical operating rooms, out-patient facilities, clinics and hospitals throughout the world. However, predictable, consistent, repeatable and effective results are not typically achieved and procedures are not always as safe as they should be. The variety of supplies, equipment, techniques, and procedural steps used to prepare adipose tissue are often arbitrary, varying from patient-to-patient, which contributes to inconsistent outcomes. This variation can even occur within the same clinic, between different healthcare practitioners, and even when such procedures are performed by the same healthcare practitioner.
Primary reasons for the variability and inconsistencies in the current state of the art include the lack of (i) a work area that is set up in an appropriate manner, (ii) proper equipment, (iii) necessary supplies, (iv) safe and adequate consumables, and (v) an organized protocol with standardized procedures and a consistent methodological approach. Often, necessary supplies are not readily available and the various quantities of required consumables are not ordered or inventoried properly. Frequently, an inconsistent variety of supplies are used in various settings with arbitrary protocols that result in an unfortunate variety of patient-to-patient outcomes.